GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling the Optima CL 323i angiographic X-ray system, along with related Innova and Discovery fluoroscopic interventional imaging systems, due to a potential safety issue that may cause loss of C-arm gantry motion capability. The recall affects seven devices that have been distributed worldwide, including throughout the United States and in multiple countries including Canada, China, Japan, the United Kingdom, and others.
The recall notice does not specify what action affected consumers should take or what remedy is available.
Written by software from the official notice below. Not reviewed by a lawyer.
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
Reason for recall: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). Distribution: Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, GA, IL, IN, KS, MS, NV, OH, OK, OR, PA, TN, TX, VA, WA and WI; and countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAPAN, RUSSIA, UNITED KINGDOM, and VIETNAM. Quantity: 7 Lot/code info: Serial Number System ID Not Available GON4271838 Not Available 229890CL Not Available 361788CL323 Not Available 806358INNOVA 0C2V069A4104R1 082416310033 0C2V069A4202R1 082416200021 0C2V069A4203R1 082416050013
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.